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A Randomized Study in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen

NCT00201318 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2005-09-20

No results posted yet for this study

Summary

\* AIMS OF THE STUDY (STUDY OBJECTIVES)

1. To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation and hepatitis development in HBsAg (+) NHL patients.
2. To test the efficacy of daily lamivudine in preventing and treating hepatitis B reactivation and in circumventing hepatic failure and death.
3. To test whether lamivudine can improve the overall outcome of NHL patients who are HBV carriers.

(Study end-points: The major end-point: hepatitis B reactivation in NHL patients---defined by higher than 10-fold increase of serum HBV DNA level and/or reappearance of HBeAg in the serum during and within 6 months after chemotherapy. The minor end-point I : events of hepatic failure and death---defined by jaundice with hepatic encephalopathy. The minor end-point II: the response rate and survival rate in HBsAg-positive NHL patients receiving lamivudine prophylaxis and treatment.)

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Cyclophosphamide Doxorubicin Vincristine Lamivudine

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Mackay Memorial Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Chi Mei Medical Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Pei-Jer Chen, Ph.D. · National Taiwan University Hospital

  • Ann-Lii Cheng, Ph.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-30
Completion
2005-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201318 on ClinicalTrials.gov